BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 12290186 · Received August 6, 2021

    Report

    Report Number
    3006630150-2021-04343
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 13, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7083223/7083372.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT DUE TO A PSEUDOMONAS INFECTION WHICH WAS BELIEVE THAT THE PATIENT WAS A CARRIER OF THE BACTERIA. THE LEFT LOWER FLANK WHERE THE IPG WAS IMPLANTED WAS VISIBILITY RED, SWOLLEN, VERY TENDER, AND WARM TO THE TOUCH. THE MIDLINE INCISION WAS NOTED TO HAVE PUSS. THE PATIENT WAS GIVEN ORAL IV ANTIBIOTICS. EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186223 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 203423 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention